• Title/Summary/Keyword: HPLC analysis method

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Bioequivalence of Acer Capsule to Airtal Tablet (Aceclofenac 100 mg) (에어탈 정(아세클로페낙 100 mg)에 대한 에이서 캅셀의 생물학적 동등성)

  • Cho, Hea Young;Kim, Soo Jin;Oh, In Joon;Moon, Jai Dong;Lee, Yong Bok
    • Korean Journal of Clinical Pharmacy
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    • v.12 no.1
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    • pp.22-28
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    • 2002
  • Aceclofenac, 2-[(2',6'-dichlorphenyl)amino]phenylacetoxiacetic acid, is a new nonsteroidal anti-inflammatory drug that belongs to the family of phenylacetic acids. It shows good tolerance and potent analgesic/antiinflammatory properties, and acts on cartilaginous chondriocytes, stimulating their repair mechanism. The purpose of the present study was to evaluate the bioequivalence of two aceclofenac products, $Airtal^{TM}$ tablet (Daewoong Pharmaceutical Co.) and $Acer^{TM}$ capsule (Kyungdong Pharmaceutical Co.), according to the guideliner of Korea Food and Drug Administration (KFDA). The aceclofenac release from the two aceclofenac products in vitro was tested using KP VII Apparatus II method at pH 7.8 dissolution media. Sixteen normal male volunteers, $23.13\pm2.03$ years in age and $66.33\pm7.08$ kg in body weight, were divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet or capsule containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentrations of aceclofenac in serum were determined using HPLC with UV detector. The dissolution profiles of the two aceclofenac products were very similar at pH 7.8 dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_max$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two products were $6.50\%,\;-1.06\%\;and\;11.96\%$ respectively, when calculated against the $Airtal^{TM}$ tablet. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;were\;89.82\%\;and\;82.84\%$, respectively. Minimum detectable differences $(\Delta)\;at\;\alpha=0.05\;and\;1-\beta=0.8$ were less than $20\%\;(e.g.,\;17.51\%\;and\;19.30\%\;for\;AUC_t,\;C_{max}$, ). The $90\%$ confidence intervals were within $\pm20\%\;(e.g.,\;-3.73\%\sim16.73\%\;and\;-12.34\%\sim10.22\%\;for\;AUC_t,\;C_{max},\;respectively)$. Two parameters met the criteria of KFDA for bioequivalence, indicating that $Acer^{TM}$ capsule is bioequivalent to $Airtal^{TM}$ tablet.

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Bioequivalence of Terbina Tablet to Lamisil Tablet (Terbinafine 125 mg) (라미실 정(테르비나핀 125 mg)에 대한 터비나 정의 생물학적 동등성)

  • Kim, Soo-Jin;Jeong, In-Seong;Cho, Hea-Young;Shim, Young-Sun;Jeong, Tae-Jin;Oh, In-Joon;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.30 no.2
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    • pp.133-138
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    • 2000
  • Terbinafine is an orally active antifungal agent as it inhibits the fungal enzyme squalene epoxidase, which is important in the early biosynthetic pathway of ergosterol. This leads to abnormal development of the fungal cell membrane. Bioequivalence of two terbinafine tablets, $Lamisil^{TM}$ (Novartis Korea Ltd.) and $Terbina^{TM}$ (Korean Drug Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $23.56{\pm}1.75$ years old and $65.60{\pm}8.54\;kg$ of body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 125 mg of terbinafine was orally administered, blood was taken at predetermined time intervals and the serum concentrations of terbinafine were determined using an HPLC method with UV detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Lamisil^{TM}$, tablet were -2.53%, -2.98% and 8.13%, respectively. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were 85.21%, 98.21% and 93.11%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.1\;and\;1-{\beta}=0.8$ were all less than 20%. The 90% confidence intervals were all within ${\pm}20%$. All the parameters above met the criteria of KFDA for bioequivalence, indicating that $Terbina^{TM}$ tablet is bioequivalent to $Lamisil^{TM}$ tablet.

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Preparation and Release Behavior of Ipriflavone-Loaded PLGA Microsphere for Tissue Engineered Bone (이프리플라본을 함유한 생분해성 PLGA 미립구의 제조 및 조직공학적 골재생을 위한 영향평가)

  • So, Jung-Won;Jang, Ji-Wook;Kim, Soon-Hee;Kim, Geun-Ah;Choi, Jin-Hee;Rhee, John-M.;Son, Young-Suk;Min, Byoung-Hyun;Khang, Gil-Son
    • Polymer(Korea)
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    • v.33 no.1
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    • pp.26-32
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    • 2009
  • The aim of this research was to prepare microparticulate systems based on poly (lactide-co-glycolide)(PLGA) for the local release of ipriflavone in order to reduce bone loss. We developed the IP loaded PLGA microspheres using relatively simple oil-in-water(O/W) solvent evaporation method. HPLC was used to perform the in vitro release test of IP and morphology of cell attached on the micro-spheres was investigated using SEM. Cytotoxicity was assayed by cell counting kit-8 (CCK-8) test. Osteogenic differential cells were analyzed by ALP activity. Through RT-PCR analysis, we observed osteocalcin, ALP, and Type I collagen mRNA expression. The release of IP in vitro was more prolonged over 42 days and IP/PLGA microspheres showed the improvement on the cell proliferation, ALP activity and RT-PCR comparing with control (only PLGA). This initial research will be used to direct future work involved in developing this composite injectable bone tissue engineering system.

Identification of an Actinomycetes Strain, MSA-1, Originated from Sponge, Halichondria okadai, and its Antimicrobial Component (검정해면으로부터 항균성을 가진 방선균의 분리 동정 및 항균물질의 구조)

  • LEE Jong-Soo;CHOI Jong-Duck
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.31 no.4
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    • pp.516-522
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    • 1998
  • An Actinomycetes strain, MSA-1, containing antimicrobial component was isolated from the black sponge, Halichondzia okadai, and was identified to a genus level by morphological and chemotaxonornic methods. The gray colored spores were oval type with smooth surface and formed flexibilis spore chains. The cell wall of this strain was type I containing D-aminopimellic acid (D-DAP) and no specific sugar was detected. Phospholipid of the cell membrane was PII type including phophoethanolamine and the major fatty acids of total lipid were branched anteiso-15 : 0, iso-16 : 0, 16 : 0 and iso-17 ; 0. From these results and other characteristics described in the Bergey's Manual, this strain was identificated as a Streptomyces sp. Meanwhile, 10mg of pale yellow colored antimicreobial component was isolated by HPLC method from the cultured Streptomyces sp. (70g of cryophillized mycellis). By crystallographyc analysis, HIRESMS and NMR assignment, the antimicrobial component produced from the strain MSA-1 was elucidated as the staurosporine (indolo[2,3-a]carbazole alkaloid).

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Bioequivalence Test of Gabapentin 400 mg Capsules (가바펜틴 400밀리그람 캡슐의 생물학적동등성시험)

  • Kim, Se-Mi;Kang, Hyun-Ah;Cho, Hea-Young;Shin, Sae-Byeok;Yoo, Hee-Doo;Yoon, Hwa;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.195-200
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    • 2008
  • Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

Bioequivalence Test of Fexofenadine Hydrochloride 120 mg Tablets (염산펙소페나딘 120밀리그람 정제의 생물학적동등성시험)

  • Cho, Hea-Young;Kang, Hyun-Ah;Kim, Se-Mi;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.188-194
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    • 2008
  • Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.

Quantitative Analysis of Paeoniflorin and Paeonol in Peony Extracts and Quality Control Standards (모란 추출액에서 paeoniflorin과 paeonol 동시 정량 분석 및 화장품 원료의 품질관리 기준 설정)

  • Yun, Ki-Hun;Chi, Yong-Ha;Lee, Dong-Kyu;Paik, Soo-Heui
    • Journal of the Korean Applied Science and Technology
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    • v.35 no.1
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    • pp.235-246
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    • 2018
  • Paeony has pharmacological activities such as anti-inflammatory, anti-allergic, anti-bacterial, central inhibitory, gastric secretion inhibition, and antispasmodic activities. In addition, its antioxidant activity and whitening effect being reported, thus it is being explored as raw materials for cosmetics. We compared the changes in the contents of paeoniflorin and paeonol in Peony extracts, depending on the changes of extracting solvents, temperature and time. The HPLC method was set up for simultaneous analysis, the system suitabilities were confirmed by using the calibration curves and the QC samples for each assay batch. Paeonol was detected only in roots, and paeoniflorin was higher in leaf and flower than root. Higher concentrations of both ingredients were extracted when the root was used after grinding to a suitable size, and when 30% 1,3-butylene glycol was used as the extraction solvent. Also the concentrations tended to increase at higher temperature and longer time, but the increase was gradual at over $75^{\circ}C$ and 4 hours. The ratio of root, leaf and flower was determined to be 2+2+1g/0.5kg of batch, reaching the contents criteria of paeoniflorin and paeonol. Finally, we selected as the best extraction condition when the raw materials are mixed with 2+2+1g/0.5kg and extracted with 30% 1,3-butylene glycol as an extraction solvent at $75^{\circ}C$ for 4 hours, considering both the concentrations of two components and the cost of raw materials and manufacturing process, The extraction units were scaled up to 10 kg under this condition.

Seasonal distribution and primary production of microphytobenthos on an intertidal mud flat of the Janghwa in Ganghwa Island, Korea (강화도 장화리 갯벌에서 저서미세조류의 계절적 분포 및 일차 생산력)

  • Yoo, Man-Ho;Choi, Joong-Ki
    • The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
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    • v.10 no.1
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    • pp.8-18
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    • 2005
  • We studied seasonal distribution of the microphytobenthos and their primary production with $C^{14}$ method and carried out pigment analysis with HPLC in an estuarine mudflat of the Ganghwa Island, Korea from May 2002 to April 2004. The abundances of microphytobenthos were higher at the middle than upper part and lower part of intertidal flat. Abundances of microphytobenthos ranged from $2.3{\times}10^5\;cells\;cm^{-2}$ to $140.9{\times}10^5\;cells cm^{-2}$. The bloom of microphytobenthos was observed in the early spring and then it decreased from spring to summer and autumn. The pennate diatom was a predominated group among the microphytobenthos in this area. The dominant species were Paralia sulcata, Cylindrotheca closterium and Nitzschia sp.. Nitzschia sp. and Cylindrotheca closterium were predominant in February. The results of pigment analysis suggest the presence of diatoms, euglenophytes, chlorophytes, cyanobacteria, cryptophytes, chrysophytes, prymnesiophytes, dinoflagellates and prasinophytes. The biomass of microphytobenthos ranged from 1.18 to 34.25 mg chl-a $m^{-2}$, with a mean of 7.60 mg chl-a $m^{-2}$. The mean ratio of Fuco/Chl a was 0.7 which indicates that most of biomasses of microphytobenthos were due to diatoms. The ratios of Chl b/Chl a ranged from 0 to 0.82(with a mean of 0.17), implying that euglenophytes and chlorophytes lived together in special period seasonally. Temporal variation of primary production ranged from 4.2 to 113.0 $mgC{\cdot}m^{-2}{\cdot}hr^{-1}$(mean value was 33.9 $mgC{\cdot}m^{-2}{\cdot}hr^{-1}$ and initial slope$({\alpha})$ was measured from 0.002-0.005$(mgC\;mgchl-a^{-1}\;hr^{-1}){\cdot}({\mu}E\;m^{-2}\;s^{-1})^{-1}$. Assimilation number$(P_m)$ was in the range of 0.50-1.32 $mgC{\cdot}mgChl-a{\cdot}hr^{-1}$ and daily primary production ranged from 20.9 to 678.1 $mgC{\cdot}m^{-2}{\cdot}d^{-1}$(mean value was 206.72 $mgC{\cdot}m^{-2}{\cdot}^{-1}$).

LC-MS/MS analysis and antioxidant activity of Dendropanax morbiferus extract. (황칠나무(Dendropanax morbiferus) 잎 추출물의 LC-MS/MS 분석 및 항산화 효과)

  • Min Jung Kim;Jae Dong Son;Ye Jin Yang;Ji Woong Heo;Hu Jang Lee;Kwang Il Park
    • Herbal Formula Science
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    • v.32 no.3
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    • pp.235-245
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    • 2024
  • Objective : The study's objective is to assess the components of Dendropanax morbifera (DM) utilizing UPLC-MS/MS and assess their antioxidant properties in order to establish fundamental information for quality control of herbal formulations. Methods : The DM leaves were ground into powder and extracted with water at 80℃. The extract was subsequently concentrated and subjected to freeze-drying for subsequent analysis. The LC-MS/MS analysis was performed using a 1260 series HPLC system and a 3200 QTrap tandem mass system in positive ion mode, with detection conducted at 280 nm. The Folin-Ciocalteu method was employed to measure the phenolic content, while a colorimetric method using aluminum chloride was used to determine the flavonoid content, with gallic acid and quercetin as standards, respectively. The evaluation of antioxidant activity was conducted through the measurement of DPPH radical scavenging activity, by adding the DPPH solution to the extract and recording the absorbance at 517 nm. Results : The UPLC-MS/MS analysis identified five polyphenolic compounds in the DM extract, specifically syringin, 6-hydroxyluteolin 7-O-laminaribioside, shaftoside, rutin, and kaempferol-3-O-rutinoside. The extract was found to contain a total phenolic content of 83.106 ± 0.21 mg GAE/g and a total flavonoid content of 87.963 ± 1.014 mg QE/g. The DM extract demonstrated substantial antioxidant properties, resulting in a reduction of DPPH radicals that was evident at concentrations as low as 40 ㎍/㎖. Conclusions : The study determined important polyphenolic compounds in DM and established its considerable antioxidant efficacy. These findings provide evidence for the efficacy of DM in disease prevention related to oxidative stress and establish a foundation for ensuring quality control in herbal preparations.

Evaluation of Enzymatic Method using an Automated Chemistry Analyzers for Homocysteine Measurement

  • Shim, Moon-Jung
    • Korean Journal of Clinical Laboratory Science
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    • v.39 no.3
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    • pp.196-200
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    • 2007
  • In clinical practice, homocysteine has gained popularity because its elevated values are strongly associated with an increased risk of cardiovascular disease. More recently, a new enzymatic colorimetric assay for homocysteine in biological sample, suitable for automated clinical analyzers, has been proposed. To evaluate one of these enzymatic methods and compare the results obtained with this method with those of an immunoenzymatic method, thirty-two samples were analyzed for total homocysteine by HiSens$^{(R)}$ homocysteine reagent on the automated chemistry analyzers TBA 200FR and compared to the widely used immunoenzymatic method ADVIA Centaur. In TBA 200FR, the within-run CVs of two control materials were 3.23% and 0.92%, respectively; the between run CVs were 4.58% and 2.55%, respectively. And in ADVIA 1650, the within-run CVs were 6.81% and 0.99%, respectively; the between run CVs were 9.0% and 3.9%, respectively. The recovery for homocysteine was 100% ($60.8{\mu}mol/L$), 99.1% ($48.64{\mu}mol/L$), 96.3% ($36.48{\mu}mol/L$), 96.1% ($24.32{\mu}mol/L$), and 92.1% ($12.16{\mu}mol/L$). The regression equation of TBA 200FR vs. ADVIA Centaur was y=0.9095x-2.5086 (r=0.9632). And the regression equation for the ADVIA 1650 chemistry vs. Immulite 2000 was y=0.8418x + 0.3207 (r=0.9625). In conclusion, this enzymatic method using automated chemistry analyzer for homocysteine assay shows acceptable analytical performance. I suggest that this assay will be suitable for routine analysis.

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